Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)

Abstract

The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), a clinical trial of the investigational recombinant vesicular stomatitis virus–based Ebola virus vaccine (rVSV∆ZEBOV-GP; Merck), provided an opportunity to assess health conditions in a cohort of healthy Sierra Leonean adults before vaccination. Of the 8793 healthcare and frontline Ebola response workers screened for study enrollment, 7 (0.1%) self-reported human immunodeficiency virus infection or another significant immunodeficiency disorder and 11 of 3190 (0.3%) women 18–49 years old had a positive urine pregnancy test. Of the 440 participants included in a safety substudy, 124 (28.2%) reported at least 1 medical condition at baseline, most commonly drug hypersensitivity (11.6%), arthralgia (3.9%), arthropathy (2.7%), or gastric (3.0%) or peptic (2.7%) ulcer disease. We calculated the incidence per 100 person-years (PY) and 95% confidence intervals (CIs) of new medical conditions among the 4297 participants followed for 18–24 weeks from enrollment to scheduled vaccination. The most commonly reported conditions were headache (32.4 PY [95% CI, 29.7–35.3 PY]), pain (unspecified) (17.3 PY [95% CI, 15.4–19.4 PY]), arthralgia (9.3 PY [95% CI, 7.9–10.8 PY]), and abdominal pain (9.1 PY [95% CI, 7.7–10.7 PY]). Nasopharyngitis (7.0 PY [95% CI, 5.8–8.4 PY]) and malaria (1.9 PY [95% CI, 1.3–2.7 PY]) were the most commonly reported infectious conditions. Several cases of hypertension, diabetes mellitus, and cancer were also reported. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

Operationalizing International Regulatory Standards in a Limited-Resource Setting During an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience

“…Therefore, study staff used case report forms to document participant descriptions of medical events more thoroughly than is done in a typical developed-country clinical trial setting. This practice had the added benefit of providing a snapshot of medical conditions in this population [11], for which few data had previously been available.…”